Table of ContentsView AllTable of ContentsHow Stelara WorksWho Can Take ItDosing & ScheduleSide EffectsInteractionsContraindicationsOther ConsiderationsCost and Discounts
Table of ContentsView All
View All
Table of Contents
How Stelara Works
Who Can Take It
Dosing & Schedule
Side Effects
Interactions
Contraindications
Other Considerations
Cost and Discounts
Stelara (ustekinumab) is an injectedbiologic drugused to treat moderate to severeplaque psoriasisand activepsoriatic arthritis.
This article discusses Stelara for psoriasis. It explains how Stelara works, potential side effects, and dosing information. It also provides information on the cost of Stelara and assistance programs available from the manufacturer.
Artfoliophoto / Getty Images
How Can Stelara Help Psoriasis?
Plaque psoriasis and psoriatic arthritis are both autoimmune disorders that affect the skin. Both occur when the immune system inexplicably attacks cells in the upper layer of skin (epidermis).
Antibodiesactivate the immune response unnecessarily and release inflammatory substances, calledcytokines, into the bloodstream. This leads to long-term inflammation that can be damaging to cells.
Stelara is amonoclonal antibody—a type of drug manufactured in the lab to counteract the immune response that causes the disease.
How Quickly Does Stelara Work for Psoriasis?
Stelara starts working on your immune system after the first dose. Individual results vary, but in general, Stelara improves plaque psoriasis after three months and psoriatic arthritis after six months.
In clinical trials, 60% of plaque psoriasis patients achieved clear or nearly clear skin after 12 weeks, and 70% of patients had at least 75% improvement.
For psoriatic arthritis, after 28 weeks, about half saw a 20% improvement in joint pain, tenderness, inflammation, and functioning. Roughly one-quarter of patients achieved a 50% improvement in symptoms, while only about one in 10 had at least a 70% improvement.
Who Can Take Stelara?
Stelara can be used with or without methotrexate in people ages 6 and older with psoriatic arthritis. In severe cases—such asarthritis mutilans, a rare complication—Stelara may be used in first-line combination therapy.
Stelara is also approved for the treatment of Crohn’s disease andulcerative colitis.
Dosage and How Often Stelara Is Given for Psoriasis
Stelara is administered as asubcutaneous (under the skin) injection. It is available in 45-milligrams (mg) and 90-mg single-use, prefilled syringes. It is also offered in 45-mg and 90-mg single-use vials.
The adult dose for treatment of psoriasis and psoriatic arthritis varies based on body weight as follows:
The injection is given in either the upper arm, buttock, thigh, or abdomen. It is important to change the injection site with each dose to avoid scarring (fibrosis) of the underlying tissue.
Psoriasis Injections
Stelara Side Effects
As with any other drug, there are side effects associated with Stelara use. Many are the result of immune suppression, which may leave you vulnerable to certain infections.
The most common side effects (affecting at least 3% of users) include:
Less commonly, Stelara can cause thereactivation oftuberculosis (TB). Prior to treatment, people should betested for TBand treated if an infection is detected.
Anaphylaxis(a whole-body allergic reaction) andangioedema(sudden swelling, often due to allergy) were not reported in any of the premarket studies but have since been seen in isolated cases.
If this occurs, stop taking Stelara and call your healthcare provider immediately.If left untreated, anaphylaxis can lead to shock, coma, respiratory or heart failure, and death.
When to Call 911Seek emergency care if you experience any of the following after taking Stelara:Skin rashes or hivesShortness of breathWheezingDizziness or faintingSwelling of the lips, tongue, or throatVomitingDiarrheaRapid heartbeatA feeling of impending doom
When to Call 911
Seek emergency care if you experience any of the following after taking Stelara:Skin rashes or hivesShortness of breathWheezingDizziness or faintingSwelling of the lips, tongue, or throatVomitingDiarrheaRapid heartbeatA feeling of impending doom
Seek emergency care if you experience any of the following after taking Stelara:
Stelara should not be used in people with a known hypersensitivity to ustekinumab or any of the drug’s inactive ingredients. Anyone with a previous reaction should not be rechallenged no matter how mild the reaction may have been.
Stelara should be used with caution with other immune-suppressive drugs. The cumulative effect may leave you vulnerable to a wider range of serious infections.
Among the medications of special concern:
Who Shouldn’t Use Stelara
Stelara should not be used if you have an active infection of any sort, as it suppresses the immune response and makes it harder for the body to fight back.
If you are pregnant, planning to get pregnant, or breastfeeding, speak with your rheumatologist to fully weigh the benefits and risks of Stelara use in your case. Animal studies have not shown any evidence of fetal harm, but research data is limited and insufficient to inform a drug-associated risk.
This is not a complete list of contraindications. Speak with your healthcare provider about whether Stelara is right for you.
Psoriatic Arthritis Doctor Discussion GuideGet our printable guide for your next doctor’s appointment to help you ask the right questions.Download PDFEmail AddressSign UpThank you, {{form.email}}, for signing up.There was an error. Please try again.
Get our printable guide for your next doctor’s appointment to help you ask the right questions.
Download PDF
Email AddressSign UpThank you, {{form.email}}, for signing up.There was an error. Please try again.
Sign Up
Thank you, {{form.email}}, for signing up.
There was an error. Please try again.
Thevaccines you need toavoid without exceptioninclude:
If a vaccine is recommended, ask your healthcare provider if it is live or inactivated (killed). You should also double-check with your rheumatologist to ensure getting it is safe for you.
Moreover, people should not receive the Bacille Calmette-Guerin (BCG) vaccine, used to prevent TB, one year prior to treatment or for one year after Stelara has been stopped.
Stelara may also increase the risk of certain cancers, especiallysquamous cell skin cancer. With that being said, it doesn’t appear to “cause” cancer but rather may promote cancer growth in people withpre-existing risk factors. Anyone treated with Stelara should be monitored for non-melanoma skin malignancies.
Stelara Cost and Discounts
Unfortunately, this not an inexpensive treatment. A single 90 mL pre-filled syringe of Stelara can cost in excess of $25,000 without insurance. That equals one dose of Stelara for psoriasis in a person weighing more than 220 pounds or two doses for people under 220 pounds.
Even with insurance, which is likely to require pre-authorization, the copay for Stelara can be around $1,500 per dose.
Most people require up to six doses in the first year of treatment, then four times a year thereafter. The per-dose price must be multiplied appropriately to get the total cost of using Stelara.
Prescription drug discounts are available for Stelara. Manufacturer Janssen Pharmaceuticals offers theStelar WithMe Savings Program. Eligible participants with private insurance can pay as little as $5 for the medication.
State-sponsored cost-savings programs can help reduce the cost of medication for people on Medicaid.
TheJohnson & Johnson Patient Assistance Foundationmay be able to help reduce the cost of the drug for people without insurance. Assistance is based on income and household size.
Is Generic Ustekinumab Available?
Stelara, the brand name for ustekinumab, has been on the market in the U.S. since 2009. It is currently not available in a generic formula.
However, Janssen’s patent for ustekinumab is due to expire in September 2023. Pharmaceutical companies around the globe are working to bring generic ustekinumab to the market.
4 SourcesVerywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.U.S. Food and Drug Administration.Highlights of prescribing information: Stelara (ustekinumab).Deepak P, Loftus EV Jr.Ustekinumab in treatment of Crohn’s disease: design, development, and potential place in therapy.Drug Des Devel Ther. 2016;10:3685–3698. doi:10.2147/DDDT.S102141National Psoriasis Foundation.FDA determinations for pregnant and nursing women.American Journal of Managed Care: The Center for Biosimilars.Amgen releases positive phase 3 results for Stelara biosimilar.
4 Sources
Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.U.S. Food and Drug Administration.Highlights of prescribing information: Stelara (ustekinumab).Deepak P, Loftus EV Jr.Ustekinumab in treatment of Crohn’s disease: design, development, and potential place in therapy.Drug Des Devel Ther. 2016;10:3685–3698. doi:10.2147/DDDT.S102141National Psoriasis Foundation.FDA determinations for pregnant and nursing women.American Journal of Managed Care: The Center for Biosimilars.Amgen releases positive phase 3 results for Stelara biosimilar.
Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
U.S. Food and Drug Administration.Highlights of prescribing information: Stelara (ustekinumab).Deepak P, Loftus EV Jr.Ustekinumab in treatment of Crohn’s disease: design, development, and potential place in therapy.Drug Des Devel Ther. 2016;10:3685–3698. doi:10.2147/DDDT.S102141National Psoriasis Foundation.FDA determinations for pregnant and nursing women.American Journal of Managed Care: The Center for Biosimilars.Amgen releases positive phase 3 results for Stelara biosimilar.
U.S. Food and Drug Administration.Highlights of prescribing information: Stelara (ustekinumab).
Deepak P, Loftus EV Jr.Ustekinumab in treatment of Crohn’s disease: design, development, and potential place in therapy.Drug Des Devel Ther. 2016;10:3685–3698. doi:10.2147/DDDT.S102141
National Psoriasis Foundation.FDA determinations for pregnant and nursing women.
American Journal of Managed Care: The Center for Biosimilars.Amgen releases positive phase 3 results for Stelara biosimilar.
Meet Our Medical Expert Board
Share Feedback
Was this page helpful?Thanks for your feedback!What is your feedback?OtherHelpfulReport an ErrorSubmit
Was this page helpful?
Thanks for your feedback!
What is your feedback?OtherHelpfulReport an ErrorSubmit
What is your feedback?
